On September 27, 2023, the Patented Medicine Prices Review Board (PMPRB) published its final decision regarding the Amended Interim Guidance first proposed on June 20, 2023.
Effective immediately, the proposed amendments to the Interim Guidance are implemented without changes, notwithstanding the concerns raised by many of the 45 consultation responses from stakeholders.
Key considerations for patentees are:
- New Medicines – Median International Price (MIP) Remains Benchmark PMPRB will conduct an “expedited assessment” of the prices of New Medicines. A new medicine’s price will be considered as “reviewed” if its list price is below the PMPRB11 MIP. “Reviewed” products will not be subject to further price reviews during the interim period. It is not clear whether PMPRB will reassess these products once new guidelines are in place.
Products with a list price above the PMPRB11 MIP will not be considered excessively priced – they will remain merely “under review” until new guidelines are in place. PMPRB has confirmed that once these products are reviewed under new guidelines, excess revenues calculations will not include sales made in the interim period.
- Existing Medicines – List Price FreezeNo changes were made to the interim guidance for existing medicines. Products that took a list price increase after June 2022 may be subject to an investigation.
PMPRB indicated that many submissions had comments regarding the exclusion of CPI and want to “reassure” patentees that CPI will be studied during the consultation process as new guidelines are developed.
- New Guidelines – Starting from ScratchPMPRB will launch a two-phase consultation process on the new set of guidelines in the coming weeks. They look to achieve clarity and predictability under the new Regulations and implementing the PMPRB11. The Board stresses that it will approach consultation with a “fresh and open mind”.
The first stage of the consultation will be “based on themes selected from the diverse issues and trends that impact health care, pharmaceuticals and the vast inter-connected ecosystem from lab bench to patients in Canada and around the world.” This stage is expected to begin in the coming weeks.
The second stage of the consultation process will begin sometime in 2024 leaving questions as to when final guidelines will be implemented, and how long patentees will have to comply with new price ceilings.